The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Vancomycin Assay.
| Device ID | K020692 |
| 510k Number | K020692 |
| Device Name: | EMIT 2000 VANCOMYCIN ASSAY |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414561967 | K020692 | 000 |
| 00842768023323 | K020692 | 000 |
| 00842768001109 | K020692 | 000 |